Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT00825994
Eligibility Criteria:
Inclusion Criteria:
* Women age 40 and older in the peri- or postmenopausal period, as defined in Soules et al. 2001
* Meet criteria for Major Depressive Disorder on the MINI (Mini-International Neuropsychiatric Interview)
* Score of 18 or greater on MADRS (Montgomery-Asberg Depression Rating Scale) at screening visit
* Do not meet criteria for placebo response during placebo run-in phase; placebo response is defined as a \> 50% decrease in MADRS from screening to end of placebo run-in phase
* Willing to receive treatment on an outpatient basis
* Presence of general good health
Exclusion Criteria:
* Currently pregnant, trying to conceive, or breastfeeding
* Treatment with an antidepressant medication currently or in the past 1 month
* Treatment with hormone replacement therapy currently or in the past 1 month
* Treatment with Omega-3 supplements currently or in the past 1 month
* Use of birth control pills currently or in the past 1 month
* Presence of suicidal ideation
* Meet criteria for current or within the past month for panic disorder, obsessive compulsive disorder (OCD), psychosis, mania or hypomania, as assessed by the MINI
* Diagnosis of treatment resistant Major Depressive Disorder, defined as patients who have been treated with two or more therapeutic courses of antidepressant medication without remission of symptoms for the current episode of depression, as assessed by the MINI
* Any medical condition that would make participation in the study unsafe, as determined by investigator
* Presence of a known allergy to fish or fish oil that would put participant at risk, as determined by a study investigator
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Study:
NCT00825994
Study Brief:
Protocol Section:
NCT00825994